Run routine experiments such as flow cytometry, cell culture, ELISA, qPCR, endotoxin, ect.
Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
Performs maintenance, monitoring, and troubleshooting of pertinent equipment
Performs and assists in the training of other Quality Control technicians
Maintains training records and coordinates records retention with Document Control and Training groups
Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines
Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable
Participates in managing QC materials and supplies
Performs and assists in equipment and method qualification/validation activities as needed
Performs reagent and media preparation
Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment
Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
Initiates, investigates, and prepares deviation reports with input from assigned supervisor
Brainstorms and implements corrective and preventive actions, as and when applicable
Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
Qualifications
BA/BS in a science or relevant field required
Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry for level's II-III